NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Your argument is still speculation stacked on speculation.

First, you admit there is no way to prove that a pre-BLA meeting occurred or what FDA said if it did. That should end the claim right there. You cannot turn the absence of proof into proof of a negative. There are no public facts showing that FDA told NWBO not to file, that FDA rejected the data, or that LP was trying to avoid hearing FDA’s views. That is conjecture, not evidence.

Second, your premise that a pre-BLA meeting would necessarily have been some decisive “go / no-go” event is wrong. FDA describes a pre-BLA meeting as a discussion of the proposed content of the application, major unresolved issues, and plans for submission. It is not described as a public thumbs-up or thumbs-down on ultimate approval. So even if such a meeting occurred, your theory about what FDA “must have said” still does not follow.

Third, the idea that NWBO should have “started resolving issues back in 2020” assumes facts not in evidence. You do not know what discussions may or may not have occurred, what issues may or may not have been identified, or what regulatory sequencing the company chose. What we do know from the public record is that NWBO was preparing a UK filing well before submission: on August 29, 2023, the company said it had completed prerequisites for the MHRA application and expected submission in roughly 30 to 45 days, and on December 21, 2023, it announced that the MAA had been submitted on December 20, 2023. That is a planned path, not some panicked last-minute pivot because of an unseen FDA disaster.

Fourth, for a personalized cell therapy, regulatory sequencing is not just about picking the biggest market first. It is tightly tied to manufacturing, logistics, and jurisdiction. NWBO’s UK filing fits with its established UK manufacturing infrastructure, so your “why wouldn’t they” argument ignores a major real-world consideration.

Fifth, the “radio silence” point is also overplayed. Confidential FDA interactions are confidential by default. FDA’s formal-meeting framework does not require public disclosure of whether a meeting occurred or what was discussed. So silence on that point is not some extraordinary red flag; it is entirely consistent with the normal regulatory framework unless the sponsor chooses to say more.

So the real bottom line is simple:

you are not pointing to evidence of an FDA rejection.

You are pointing to an absence of public disclosure and inventing a story around it.

That is not due diligence. That is narrative-making.